Material Transfer
Agreements
for Human Tissue Samples
Purpose
To describe Liverpool John Moores University’s procedure for the transfer or exchange of
human tissue samples for research purposes.
Application
All Principal Investigators (PIs) and all staff and students involved in the use of human
tissue samples for research purposes.
Responsibilities for Implementation
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All research staff and students involved in the use of human tissue samples
Designated Individual for Human Tissue
Persons Designated for Human Tissue
Original Document Author
Dr Sue Spiers, previous Head of Research Programme Development, Research Support
Office.
Last Review Date
A J Leigh, Head of Operation, Person Designated, June 2015
Dr P J Mintz, HTA Tissue Co-ordinator, Person Designated, June 2015
Approved By
Professor P E Wheeler, Dean, Designated Individual, June 2015
Page 1 of 5
Version: June 2015
Introduction
This policy has been produced in accordance with the requirements of The Human Tissue
Act 2004 (HT Act) and the associated Code of Practice issued by the Human Tissue
Authority (HTA)-The removal, storage and disposal of human organs and tissue.
The policy covers all research undertaken by JMU staff/students or on JMU premises which
involves the removal, storage and/or use of human tissue samples.
Key Points
1.
A material transfer agreement (MTA) is a contract that governs the
transfer/exchange of material such as human tissue from the custodian to a third
party.
2.
An MTA will usually address the following:
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Definition of the material
Restrictions on the recipients use of the material
Compliance with the Human Tissue Act (2004)
Recipients obligation to confidentially and freedom to publish
Providers access to reports and publication
Providers rights to recipients inventions and results
Intellectual Property Ownership and management
Warranty disclaimer and indemnification
Governing Law
3.
Where relevant material whether collected before or after the implementation of the
Human Tissue Act (1 September 2006) is being transferred from Liverpool John
Moores University to another organisation as part of a research project and there
are no other agreements in place to govern the transfer or where relevant material
is being supplied to a third party for their research an MTA must be in place.
4.
An MTA enables an audit trial to be maintained. Each organisation that handles
human tissue must have systems in place to record:
a. When the material was acquired and from where
b. What has been consented to
c. The uses to which the material is put whilst in the establishment’s care and any
processes applied to it
d. When the material transferred elsewhere or disposed of
5.
The agreement restricts the use of the material outside of the stated and permitted
purpose
6.
The onus to initiate an MTA is on the supplying organisation Material Transfer
Agreements for Human Tissue Samples.
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Version: June 2015
7.
Transfer of all material defined as relevant material in the Human Tissue Act (2004)
and the Human Tissue Authority (HTA) ie material, other than gametes, which
consists of or includes human cells, should be covered by an MTA.
8.
All research involving the removal, storage and / or use of human tissue must have
gained approval from an appropriate research ethics committee (REC).
9.
An MTA must be signed on behalf of both the provider and the recipient. The
relevant material defined in the MTA will be sent to the recipient upon receipt of a
fully signed and dated copy of the MTA.
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Version: June 2015
Material Transfer
Agreement
Agreement for the supply of human tissue samples for non-clinical research
Name and Address of Recipient:
Name and Address of Provider:
Material(s): (Hereinafter referred to as the ”Material”)
Nature of Work: (Hereinafter referred to as the “Work”)
I hereby acknowledge and accept that:
1.
The Material is for non-clinical research purposes only and is provided without
warranty as to its properties, merchantable quality, or fitness for any particular
purpose and without any other warranty whatsoever, express or implied and should
be used solely and exclusively for the purposes of the work.
2.
I am qualified by training and experience to perform the Work and shall be
responsible for the proper and safe handling, storage, use and disposal of the
Material in accordance with all applicable laws and regulations in my country
including but not limited to the Human Tissue Act 2004. I agree to indemnify and
hold harmless Liverpool John Moores University from any and all claims, suits and
liabilities arising from any use by me of the Material or the carrying out of the Work
under the terms of this agreement.
3.
The Material will be used solely by me or persons under my direct supervision and
control and in my laboratory. Any person involved in the Work or having access to
the Material shall be made aware of and bound by the terms of this agreement.
4.
I disclose any information whatsoever with regards to the material and use of,
without the prior written approval of Liverpool John Moores University to anyone
other than personnel engaged in carrying out the Work.
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Version: June 2015
5.
The Material shall be used only to derive such “Derivative Material” as previously
agreed in writing.
6.
Neither I nor my employer shall make any commercial use of the Material,
Derivative Material orinformation supplied by Liverpool John Moores University for
research unless such commercial use is specifically permitted by Liverpool John
Moores University for research and governed by a further written agreement to
which Liverpool John Moores University are party.
7.
In consideration of ‘Insert institution name’ supplying the Material, both
Liverpool John Moores University and ‘Insert institution name’ shall be entitled to
perpetual, royalty-free licence to use all or any of the Derivative Material and
Results for research purposes. If the use of the Material results in an invention or
discovery, the recipient is hereby granted a licence, with rights to sub-licence, to
commercially exploit the invention or discovery under any intellectual property rights
relating there to, or their right to an assignment, on terms to be agreed by Liverpool
John Moores University and ‘Insert institution name’.
8.
This agreement does not permit ‘Insert institution name’ to transfer or distribute
any part of the materials or its derivatives to any third party whatsoever.
ON BEHALF OF ‘Insert institution name’
Signature ................................................................................................................................
Name ......................................................................................................................................
Designation (can not be the individual investigator)……………………………………………
Date ........................................................................................................................................
ON BEHALF OF Liverpool John Moores University
Signature ................................................................................................................................
Name ......................................................................................................................................
Designation (Dean-Professor Peter Wheeler or Head of Operations-Aly Leigh
Date ........................................................................................................................................
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Version: June 2015